Table 1.

Characteristics of completed randomized controlled trials of tocilizumab for patients with coronavirus disease 2019 (COVID-19)

RCT	Design	Number of patients	Country, centres	Inclusion criteria	Tocilizumab	Primary outcome	Composite outcome used in meta-analysis	Completed versus stopped early
RCT-TCZ-COVID-19 NCT04346355	Open label	60 TCZ versus 66 Controls	Italy, 24 centres	COVID-19 pneumonia documented by radiological imaging, PaO2/FIO2 between 200 and 300 mmHg, and an inflammatory phenotype defined by fever and elevated CRP	8 mg/kg up to a maximum of 800 mg, followed by a second dose after 12 hours	Composite outcome: entry into the ICU with MV, death from all causes, or clinical aggravation documented by the finding of a PaO2/FIO2 ratio <150 mmHg, whichever came first	Death or continuous need for hospitalization at day 30	Stopped early for futility
CORIMUNO-19 NCT04331808	Open label	64 TCZ versus 67 controls	France, 9 centres	COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to ICU	8 mg/kg on day 1 and on day 3 if clinically indicated	Scores >5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including non-invasive ventilation) at day 14	Death or continuous need for hospitalization at day 28	Completed
BACC Bay Tocilizumab Trial NCT04356937	Double-blind, placebo-controlled trial	161 TCZ versus 81 controls	USA, 7 centres	(SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation >92%	Single dose of tocilizumab 8 mg/kg	Intubation or death	Mechanical ventilation or death at day 28	Completed
COVACTA NCT04320615	Double-blind, placebo-controlled trial	294 TCZ versus 144 controls	Nine countries (Canada, Denmark, France, Germany, Italy, The Netherlands, Spain, United Kingdom, United States), 67 centres	Patients ≥18 years with severe COVID-19 pneumonia confirmed by PCR test in any body fluid and evidenced by bilateral chest infiltrates. Blood oxygen saturation ≤93% or partial pressure of oxygen/fraction of inspired oxygen <300 mm/Hg	8 mg/kg infusion, maximum 800 mg second infusion could be administered 8–24 hours after the first	Clinical status on a 7-category ordinal scale at day 28 (1, discharged/ready for discharge; 7, death)	Death, withdrawal during hospitalization, transfer to ICU, or requirement for invasive mechanical ventilation within 28 days of baseline	Completed
EMPACTA NCT04372186	Double-blind, placebo-controlled trial	194 TCZ versus 195 controls	Six countries (Brazil, Kenya, Mexico, Peru, South Africa, US), 69 centres	COVID-19 pneumonia confirmed by PCR of any specimen and radiographic imaging SpO2 <94% while on ambient air	8 mg/kg × 1, Possible second dose	Death or MV by day 28	Death or MV by day 28

NIV, non-invasive ventilation, PaO₂/FIO₂, ratio of partial pressure of arterial oxygen to fraction of inspired oxygen; HFNC, high-flow nasal cannula; MV, mechanical ventilation respiratory support; DNR, do not resuscitate; ARDS, acute respiratory distress syndrome; CRP, C-reactive protein; PaO₂, arterial partial pressure of oxygen; FiO₂, inspired fraction of oxygen; SpO₂, oxygen pulse oximetry; ICU, intensive care unit; WHO, World Health Organization; PCR, polymerase chain reaction; TCZ, tocilizumab.